Bipolar DisorderPhase 2NCT00001545
Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
A Phase 2 study testing Magstim Super Rapid Magnetic Stimulator and Cadwell MES-10 in people with Bipolar Disorder and Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bipolar Disorder, Mood Disorder, Unipolar Depression
- What is being tested?
- Magstim Super Rapid Magnetic Stimulator and Cadwell MES-10
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- May 1996to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients will receive a psychiatric and physical examination by a qualified physician.
- Patients will be from 18 to 90 years of age and must give informed consent.
- Unipolar patients must be medication free to participate. Patients with bipolar disorder depression may be medication-free or on any combination (including monotherapy) of lithium, carbamazepine, and valproate. Inpatient monitoring will be provided when medically indicated.
Who cannot join
- Reasons for exclusion will be the presence of cardiac pacemakers, medication pumps, cochlear implants or metal objects in the head or eyes that could be dangerous if heated or moved by the magnetic pulses.
- General contraindications to rTMS or a current diagnosis of alcohol or substance abuse.
- Subjects having serious medical illnesses or meeting current psychoactive substance dependence will be excluded from entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of rTMS in the Treatment of Mood Disorders
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a new technique for activating the brain noninvasively through the scalp and skull. It has proven effective in producing localized effects on brain function and has opened many areas of human brain function to direct investigation. Preliminary data also suggest potential therapeutic applications in neuropsychiatric illness. We plan to further investigate the possible therapeutic use of rTMS in depression under conditions of high frequency (20 Hz), low (1Hz) frequency, and sham and to also examine possible cognitive or endocrine effects. Among the priorities of this protocol will be to further evaluate the risks of the technique.
- Conditions
- Bipolar Disorder, Mood Disorder, Unipolar Depression
- Being tested
- Magstim Super Rapid Magnetic Stimulator, Cadwell MES-10
- Keywords
- Affective Disorders, Repetitive Transcranial Magnetic Stimulation, Mania, Bipolar Disorder, Depression, Unipolar Disorder, Unipolar Depression
- Medical subject headings
- Bipolar Disorder, Mood Disorders, Depressive Disorder, Mania, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim Super Rapid Magnetic StimulatorDevice
Cadwell MES-10Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startMay 1996
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 91 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001545
- Sponsor's protocol ID
- 960086
- Other IDs
- 96-M-0086
- Status last verified
- Jul 2006
- First submitted
- 3 Nov 1999
- Last updated
- 13 Jul 2006
- Results posted
- No
Publications
Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.
PubMed 11137053
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of rTMS in the Treatment of Mood Disorders
- ClinicalTrials.gov ID
- NCT00001545
- Acronym / sponsor ID
- 960086
- Conditions
- Bipolar Disorder, Mood Disorder, Unipolar Depression
- Keywords
- Affective Disorders, Repetitive Transcranial Magnetic Stimulation, Mania, Bipolar Disorder, Depression, Unipolar Disorder, Unipolar Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- May 1996
- Study completion
- Jul 2006
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a new technique for activating the brain noninvasively through the scalp and skull. It has proven effective in producing localized effects on brain function and has opened many areas of human brain function to direct investigation. Preliminary data also suggest potential therapeutic applications in neuropsychiatric illness. We plan to further investigate the possible therapeutic use of rTMS in depression under conditions of high frequency (20 Hz), low (1Hz) frequency, and sham and to also examine possible cognitive or endocrine effects. Among the priorities of this protocol will be to further evaluate the risks of the technique.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients will receive a psychiatric and physical examination by a qualified physician.
- Patients will be from 18 to 90 years of age and must give informed consent.
- Unipolar patients must be medication free to participate. Patients with bipolar disorder depression may be medication-free or on any combination (including monotherapy) of lithium, carbamazepine, and valproate. Inpatient monitoring will be provided when medically indicated.
Key exclusion criteria (3 listed)
- Reasons for exclusion will be the presence of cardiac pacemakers, medication pumps, cochlear implants or metal objects in the head or eyes that could be dangerous if heated or moved by the magnetic pulses.
- General contraindications to rTMS or a current diagnosis of alcohol or substance abuse.
- Subjects having serious medical illnesses or meeting current psychoactive substance dependence will be excluded from entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim Super Rapid Magnetic Stimulator | Device | – |
| Cadwell MES-10 | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2006.
- Background: PubMed 11137053Speer AM, Kimbrell TA, Wassermann EM, D Repella J, Willis MW, Herscovitch P, Post RM. Opposite effects of high and low frequency rTMS on regional brain activity in depressed patients. Biol Psychiatry. 2000 Dec 15;48(12):1133-41. doi: 10.1016/s0006-3223(00)01065-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magstim Super Rapid Magnetic Stimulator and Cadwell MES-10 in people with Bipolar Disorder and Mood Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2006.